Cancellous Bone Bleeding Clinical Trial
Official title:
A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
| Verified date | April 2017 |
| Source | St. Teresa Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | March 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients undergoing a planned elective orthopaedic or spinal surgical procedure. Spinal surgery can be the entire spine although it should be confined to one or two-level fusions e.g. one or two level cervical, or thoracic or lumbar. - Patient has an intraoperative bleeding site involving cancellous bone that the surgeon would typically treat with another topical haemostatic agent to control the bleeding. - Patient has normal liver function - The subject is willing and able to comply with the requirements of the study protocol, including the six weeks follow-up evaluation. Exclusion Criteria: - Is unable or unwilling to return for the follow-up visit. - The subject has had surgery at the intended application site = 6 months before the current surgical procedure. - Active infection at the surgical site. - Pregnancy, as determined by urine pregnancy test, or breast feeding. - Pre-operative platelet count < 150,000, INR > 1.3, and/or APTT > 32.4. - Pre-operative anaemia (Hb < 110 g/L in females, Hb < 120 g/L in males). - Use of anticoagulant therapy (e.g., coumadin, heparin, clopidogrel), non-steroidal anti-inflammatory medications or fish oil supplements within 7 days of the surgery except for aspirin. (maximum dose 150 mg per day) - Patient with a blood dyscrasia. - Presence of a spinal tumour, intradural pathology, or prior spinal fusion surgery at the same target site. - Participation in another clinical trial with an investigational drug or device within the past 30 days. - Known allergy to human fibrinogen, human thrombin, or porcine-derived products. - Compromised immune system. - The use of a haemostatic agent is contraindicated for the subject. - Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment. - Haematological disease (thromboembolic events, haemoglobinopathy, coagulopathy or haemolytic disease) - Significant co-morbidities: Previous myocardial infarction (MI); severe ischemic heart disease (New York Heart Association Class III, IV); severe pulmonary disease; chronic renal failure; hepatic failure; uncontrolled hypertension. - Subject is unwilling to receive blood products. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Helse Møre og Romsdal HF, Ålesund sjukehus | Ålesund | |
| Norway | Helse Møre og Romsdal HF, Kristiansund sjukehus | Kristiansund | |
| United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
| United Kingdom | Castle Hill Hospital | Cottingham | |
| United Kingdom | Doncaster Royal Infirmary | Doncaster | Yorkshire |
| United Kingdom | Royal Victoria Infirmary | Newcastle upon Tyne | |
| United Kingdom | Jones & Hunt Orthopaedic Hospital | Oswestry | Shropshire |
| United Kingdom | Salford Royal Infirmary | Salford | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| St. Teresa Medical |
Norway, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes | 3 minutes | ||
| Primary | Incidence of device-related adverse events | 6 weeks | ||
| Secondary | Proportion of patients needing a repeat application of the dressing | intra-operative | ||
| Secondary | Proportion of repeat applications that achieve haemostasis | intra-operative | ||
| Secondary | Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT) | 6 weeks | ||
| Secondary | Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT) | 6 weeks | ||
| Secondary | Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR) | 6 weeks | ||
| Secondary | Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen | 6 weeks | ||
| Secondary | Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire | intra-operative | ||
| Secondary | Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire | intra-operative | ||
| Secondary | Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire | intra-operative | ||
| Secondary | Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire | intra-operative | ||
| Secondary | Mean volume of blood loss through the standard of care of the hospital | 24 hours |